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Diss Factsheets
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EC number: 296-473-8 | CAS number: 92704-41-1 The product of high temperature calcination (above 450°C (842°F)) of naturally occurring kaolin, a hydrated aluminum silicate, resulting in the evolution of water and the formation of new substances depending upon the calcination temperatures employed.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, sufficiently documented, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Urinary silicon excretion by rats following oral administration of silicon compounds.
- Author:
- Benke, G.M. and Osborn, T.W.
- Year:
- 1 979
- Bibliographic source:
- Food Cosmet. Toxicol. 27:123-127
Materials and methods
- Objective of study:
- excretion
- Principles of method if other than guideline:
- The rate of sodium silicate excretion was obtained from data on urinary excretion in rats after single oral administration of sodium aluminosilicate, Zeolite A, sodium silicate and magnesium trisilicate. Only data for sodium aluminosilicate were described in this entry.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): sodium aluminosilicate, tradename: Zeolex (Huber Corporation)
- Analytical purity: no data
- Other: Huber Corporation specified that this compound met all the purity and quality specifications of the Food Chemicals Codex; the analyses showed that it contained 30 % silicon and 5.4% aluminium.
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley Cox
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 240-260 g
- Diet (e.g. ad libitum): Purina Rat Chow (1500-2000 ppm silicon)
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 4-5 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: All suspensions were prepared in quartz-distilled water which contained < 0.5 ppm silicon and aluminium. Concentrations (w/w) of dosing materials were adjusted so that all groups received the same dosage volume (10 mL/kg). The acutal weights administered were calculated by difference.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
40, 200 and 1000 mg/kg bw
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- yes
- Positive control reference chemical:
- yes, 4 control animals received 10 mL of quartz-distilled water.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine
- Other:
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- At the 40 mg/kg level 12.4 % of administered sodium aluminosilicate was excreted in the urine, elevated levels of Si in the urine were observed only in the first 24 h after oral dosing. At the 200 and the 1000 mg/kg level 5.2 % and 1.3 % of the total administered test substance was excreted in the urine. The urinary excretion half-life for ingested sodium aluminosilicate was calculated to be 38 h. No significant increase in urinary aluminium was detected. Daily urinary aluminium excretion averaged 17.7 ± 3.2 µg for control rats and 15.1 ± 4.3 µg for sodium aluminosilicate treated rats. The excretion rate was independent of the doses applied indicating that the limiting factor is the rate of production of soluble or absorbable silicon in the gastrointestinal tract.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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